Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Reported: May 28, 2025 Initiated: April 11, 2025 #Z-1760-2025
Product Description
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Reason for Recall
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Details
- Recalling Firm
- Centerline Biomedical Inc
- Units Affected
- 80 units
- Distribution
- US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter. Recalled by Centerline Biomedical Inc. Units affected: 80 units.
Why was this product recalled? ▼
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 28, 2025. Severity: Critical. Recall number: Z-1760-2025.
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